Long-term efficacy and safety of newer generation ultrathin strut drug-eluting stents: a systematic review and meta-analysis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
B Lattuca ◽  
X Odorico ◽  
B.V Occean ◽  
L Cornillet ◽  
L Schmutz ◽  
...  

Abstract Background Recent trials have demonstrated that short-term efficacy and safety of ultrathin strut drug-eluting stents (DES) were non-inferior to contemporary stents but long-term benefit remains uncertain. Purpose The main objective of this meta-analysis was to evaluate efficacy and safety of ultrathin strut DES with an extended follow-up in comparison to 2nd and 3rd generations DES. Methods A double-blind review of randomized controlled trials (RCT) comparing ultrathin strut DES to contemporary DES was performed from MEDLINE and CENTRAL databases and from cardiological congresses. The primary efficacy endpoint was target vessel failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR) and the primary safety endpoint was occurrence of stent thrombosis (ST). Short (1 year) and long term (≥2 years) effects were estimated separately. This analysis was pre-specified in PROSPERO (CRD42019142206). Results The meta-analysis included 13 RCT including 19,490 patients. In short term, we found TLF decrease with ultrathin strut DES (RR 0.85, CI [0.75–0.97], p=0.01), driven by lower TV-MI (RR 0.83, CI [0.66–1.03], p=0.1) and TLR (RR 0.77, CI [0.58–1.01], p=0.1) rates, and a non-significant downward trend in ST (RR 0.85 CI [0.64–1.14]). In long term, from the 5 trials with extended follow-up, there was no significant difference between ultrathin strut DES and thicker strut stents in rate of TLF at the longest available follow-up (RR 0.90, CI [0.76–1.06], p=0.2), despite a numerically reduction of TV-MI (RR 0.81, CI [0.61–1.08], p=0.05) and TLR (RR 0.85, CI [0.69–1.04], p=0.1) in favor of ultrathin strut stents. However, we observed a persistent numerically reduction in ST (RR 0.79, CI [0.61–1.02], p=0.01). Conclusion Ultrathin strut DES was associated with a lower target lesion failure rate at one year but not beyond 2-years follow-up. Nevertheless, the safety of the ultrathin strut stents was sustained over time with a numerically reduction of ST. Funding Acknowledgement Type of funding source: None

2014 ◽  
Vol 78 (7) ◽  
pp. 1628-1635 ◽  
Author(s):  
Tetsuma Kawaji ◽  
Hiroki Shiomi ◽  
Takeshi Morimoto ◽  
Toshihiro Tamura ◽  
Ryusuke Nishikawa ◽  
...  

2020 ◽  
Author(s):  
Yi Xu ◽  
Yimin Shen ◽  
Pengfei Zhao ◽  
Yuanyuan Han ◽  
Jun Jiang

Abstract Background: This network meta-analysis was committed to evaluating the efficacy and safety of different dual antiplatelet therapies (DAPTs) after percutaneous coronary intervention (PCI) with drug-eluting stents (DESs).Methods: Randomized controlled trials (RCTs) comparing two of the following DAPT strategies: long-term (>12 months) DAPT (L-DAPT), 12-months DAPT (DAPT 12Mo), short-term (≤6 months) DAPT followed by aspirin monotherapy (S-DAPT+ASA), short-term DAPT followed by a P2Y12 receptor inhibitor monotherapy (S-DAPT+P2Y12) were searched. Primary outcomes were all-cause mortality, cardiac death, myocardial infarction (MI), stroke, major bleeding, any bleeding, definite or probable stent thrombosis (ST). This Bayesian network meta-analysis was performed with the random-effects model.Results: Twenty-four RCTs (n=81,376) were included. L-DAPT increased the risk of major bleeding (OR 2.37, 95%CI 1.32-5.03 compared with S-DAPT+P2Y12) and any bleeding (OR 2.95, 95%CI 1.91-4.34 compared with S-DAPT+P2Y12). When compared with L-DAPT, DAPT 12Mo (OR 1.54, 95%CI 1.13-2.02) and DAPT+ASA (OR 1.67, 95%CI 1.22-2.19) were associated with higher rates of MI, but S-DAPT+P2Y12 obtained no statistical difference. The sensitivity analysis revealed that the risks of major bleeding and any bleeding further increased for ≥18 months of DAPT. In the subgroup analysis, short-term DAPT (S-DAPT) presented similar efficacy and safety to DAPT 12Mo for patients with the acute coronary syndrome (ACS), and lower risks of major bleeding and all-cause mortality were observed in S-DAPT+P2Y12 among patients with newer-generation DES.Conclusions: S-DAPT+P2Y12 presented superiority in patients with all clinical presentations, for a lower risk of bleeding and not associated with increased ischemic harm. Besides, prospective research between aspirin monotherapy and P2Y12 monotherapy was required.


Author(s):  
Feng Li ◽  
Jin-Yu Sun ◽  
Li-Da Wu ◽  
Jian-feng Hao ◽  
Ru-Xing Wang

Backgroud The long-term outcomes of this combined procedure remain elusive. This meta-analysis aimed to assess the long-term efficacy and safety of combined procedure. Methods PubMed, Embase, Cochrane Library, and Web of Science were systematically searched from the establishment of databases to 1 January 2021. Studies on the long-term (defined as a mean follow-up of approximately 12 months or longer) efficacy and safety outcomes of combined ablation and LAAC were included for meta-analysis. Results A total of 16 studies comprising 1,428 patients were included in the meta-analysis. The pooled long term freedom rate from atrial arrhythmia was 0.66 (95% confidence interval [CI], 0.59-0.71), long-term successful rate sealing of LAAC was 1.00 (95% CI, 1.00-1.00), and ischemic stroke/transient ischemic attack/systemic embolism during follow-up was 0.01 (95% CI, 0.00-0.02). Meanwhile, the rates of peri-procedural adverse events included phrenic nerve palsy, intracoronary air embolus, device embolization, peri-procedural death of 0.00 (95% CI, 0.00-0.00), procedure-related bleeding events of 0.03 (95% CI, 0.02-0.04), and pericardial effusion requiring or not requiring intervention of 0.00 (95% CI, 0.00-0.01). Moreover, the rates of long-term adverse events rate included device dislocation, intracranial bleeding, and pericardial effusion requiring or not requiring intervention, and all-cause mortality of 0.00 (95% CI, 0.00-0.00), device embolization of 0.01 (95% CI, 0.00-0.01), and other bleeding events of 0.01 (95% CI, 0.00-0.03). Conclusion This meta-analysis suggests that the strategy of combined atrial ablation and LAAC is effective and safe during long-term follow-up


Open Heart ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e001394 ◽  
Author(s):  
Mohammad Riashad Monjur ◽  
Christian F Said ◽  
Paul Bamford ◽  
Michael Parkinson ◽  
Richard Szirt ◽  
...  

ObjectivesDetermine whether an ultrathin biodegradable polymer sirolimus-eluting stent (‘Orsiro’—BP-SES) has clinical benefits over second-generation durable polymer drug-eluting stents (DP-DES).MethodsWe conducted a prospective systematic review and meta-analysis of randomised clinical trials comparing Orsiro BP-SES against DP-DES (PROSPERO Registration: CRD42019147136). The primary outcome was target lesion failure (TLF): composite of cardiac death, target vessel myocardial infarction (TVMI) and clinically indicated target lesion revascularisation (TLR)) evaluated at the longest available follow-up.ResultsNine trials randomised 11 302 patients to either Orsiro BP-SES or DP-DES. At mean weighted follow-up of 2.8 years, the primary outcome (TLF) occurred in 501 of 6089 (8.2%) participants with BP-SES compared with 495 of 5213 (9.5%) participants with DP-DES. This equates to an absolute risk reduction of 1.3% in TLF in favour of Orsiro BP-SES (OR 0.82; 95% CI 0.69 to 0.98; p=0.03). This was driven by a reduction in TVMI (OR 0.80; 95% CI 0.65 to 0.98; p=0.03). There were no significant differences in other clinical endpoints: cardiac death, TLR and stent thrombosis.ConclusionThe Orsiro BP-SES shows promising clinical outcomes in patients undergoing percutaneous coronary intervention compared with contemporary second-generation DES at a short to medium term follow-up. More research is warranted to evaluate performance over a longer follow-up period and in different clinical and lesion subsets.


2018 ◽  
Vol 47 (12) ◽  
pp. 3019-3029 ◽  
Author(s):  
Jayson Lian ◽  
Amin Mohamadi ◽  
Jimmy J. Chan ◽  
Phillip Hanna ◽  
David Hemmati ◽  
...  

Background: Numerous treatment options have been proposed for enthesopathy of the extensor carpi radialis brevis (eECRB). Purpose: To (1) compare the efficacy and safety of nonsurgical treatment options for eECRB described in randomized placebo-controlled trials at short-term, midterm, and long-term follow-up and (2) evaluate outcomes in patients receiving placebo. Study Design: Systematic review and meta-analysis. Methods: Following PRISMA guidelines, 4 electronic databases were searched for randomized placebo-controlled trials for eECRB. Studies reporting visual analog scale (VAS) for pain scores and/or grip strength were included. Random- or fixed-effects meta-analysis was employed to compare treatments with at least 2 eligible studies using the standardized mean difference and odds ratio. The study protocol was registered at PROSPERO (ID: CRD42018075009). Results: Thirty-six randomized placebo-controlled trials, evaluating 11 different treatment modalities, with a total of 2746 patients were included. At short-term follow-up, only local corticosteroid injection improved pain; however, it was associated with pain worse than placebo at long-term follow-up. At midterm follow-up, laser therapy and local botulinum toxin injection improved pain. At long-term follow-up, extracorporeal shock wave therapy provided pain relief. With regard to grip strength, only laser therapy showed better outcomes in comparison with placebo. While there was no difference among various treatments in the odds ratio of an adverse event, they all increased adverse events compared with placebo. In placebo-receiving patients, a sharp increase in the percentage of patients reporting mild pain or less was observed from 2% at short-term follow-up to 92% at midterm follow-up. Conclusion: Most patients experienced pain resolution after receiving placebo within 4 weeks of follow-up. At best, all treatments provided only small pain relief while increasing the odds of adverse events. Therefore, if clinicians are inclined to provide a treatment for particular patients, they may consider a pain relief regimen for the first 4 weeks of symptom duration. Patient-specific factors should be considered when deciding on treatment or watchful waiting.


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